Key Points

• District of New Jersey denies early dismissal of Hatch‑Waxman patent infringement claims, reflecting that ANDA defendants face a high bar for judgment on the pleadings where claim construction and product formulation issues remain disputed.
• Court finds plausible allegations of both literal infringement and infringement under the doctrine of equivalents in litigation involving a generic version of OMIDRIA®, emphasizing that equivalency analysis is fact‑intensive.
• Decision reinforces relaxed pleading standards in ANDA litigation, recognizing that generic drug formulation details are uniquely within the ANDA filer’s control.

A High Bar for Dispositive Relief

The filer of an abbreviated new drug application (ANDA) looking to win early dismissal of Hatch-Waxman patent claims faces a steep climb — and a recent decision from the District of New Jersey illustrates why.

In her 11-page opinion in Rayner Surgical Inc. v. Somerset Therapeutics, LLC , U.S. District Judge Georgette Castner denied a defense motion for judgment on the pleadings in a Hatch-Waxman patent infringement action that involves OMIDRIA®, a combination pharmaceutical product containing ketorolac, phenylephrine, and a buffer system used during cataract surgery.

Judge Castner found genuine factual disputes on both literal infringement and the doctrine of equivalents, reinforcing the high bar for dispositive relief at the pleadings stage in ANDA litigation.

Procedural Background and the Dispute

This case has an unusual procedural wrinkle: the defendant filed its 12(c) motion in July 2025, with initial briefing concluding on August 18. Although defendant had filed its opening Markman brief in June, plaintiffs’ responsive brief was not filed until August 28, and the Markman hearing was held in November 2025. Thus, claim construction was incomplete at the time of the initial briefing for the motion. The Court issued its Markman decision on January 21, 2026, and on the same day ordered supplemental briefing regarding the extent to which the claim construction ruling impacted the pending motion for judgment on the pleadings. The parties completed supplemental briefing in February.

The central dispute turned on the Court’s claim construction of the term “phenylephrine, ketorolac, and a buffer system,” which the Court had construed to mean “a formulation with at least three separate components: (1) phenylephrine, (2) ketorolac, and (3) a buffer system.” Defendant argued that because its product does not contain a buffer system that is separate and distinct from the active pharmaceutical ingredients, plaintiffs’ allegations of both literal infringement and infringement under the doctrine of equivalents fail as a matter of law. Plaintiffs countered that factual questions remained as to whether components in defendant’s product satisfy the construed claim limitations, and that such questions could not be resolved at the pleadings stage.

Relaxed Pleading Standard in Hatch-Waxman Cases

The Court first rejected defendant’s argument that plaintiff's complaint was deficient for relying on “unsupported allegations.” Citing established precedent, the Court recognized that Hatch-Waxman plaintiffs are afforded a relaxed pleading standard because essential information about the ANDA product’s formulation lies uniquely within the defendant’s control. Indeed, a Hatch-Waxman plaintiff often files a complaint prior to receiving a defendant’s ANDA, notwithstanding Offer of Confidential Access provisions pertaining to Notice Letters which precipitate Hatch-Waxman cases. The Court held that plaintiffs had sufficiently pled their claims by alleging their “interest in the asserted patents, the filing of defendant’s ANDA, and [their] contentions that defendant’s product will infringe [those] patents.”

Literal Infringement

On the question of literal infringement, the Court declined to grant judgment on the pleadings. Accepting all factual allegations in the complaint as true, the Court found that a genuine factual dispute exists as to whether defendant’s product contains a separate and distinct buffer system under the Court’s claim construction.

The Court drew on analogous case law, including decisions from the District of Delaware, in which courts denied similar motions where the absence of a claimed component from an ANDA did not conclusively establish non-infringement as a matter of law, and thus other evidence like expert testimony was necessary.

Doctrine of Equivalents

With respect to the doctrine of equivalents (DOE), defendant argued that plaintiffs’ theory — that tromethamine, introduced in defendant’s product via ketorolac tromethamine, could serve as an equivalent of a separately added buffer system while also meeting the ketorolac limitation of the claimed invention — would impermissibly render the “buffer system” claim limitation meaningless. Plaintiffs responded that there is a factual dispute because components in defendant’s product ultimately perform substantially the same function, in substantially the same way, achieving substantially the same result as a separately added buffer system, and that the differences are insubstantial.

The Court agreed with plaintiffs that this inquiry is inherently fact-intensive and cannot be resolved on a motion for judgment on the pleadings. The Court emphasized that the DOE test is itself an intensely fact-specific determination and further held that its earlier holding during claim construction — that “the patent specification does not suggest ketorolac or phenylephrine can also serve as a buffer system” — does “not necessarily foreclose the applicability of infringement under the doctrine of equivalents.” As a result, the Court found a genuine factual dispute as to whether the components of defendant’s product are equivalent to those identified in the asserted patents.

Takeaways

This decision carries three important lessons for parties in pharmaceutical patent litigation.

First, it reaffirms the relaxed pleading standard afforded to Hatch-Waxman plaintiffs, reflecting courts’ recognition that critical formulation details are often within the exclusive possession of the ANDA filer.

Second, it illustrates the difficulty of securing early dispositive relief on infringement questions in ANDA litigation, particularly where claim construction does not unambiguously resolve the comparison between the patent claims and the accused product.

Finally, is serves as a useful reminder that the doctrine of equivalents analysis requires a thorough, fact-specific evaluation, which tends to be difficult to resolve at the pleadings stage.

Paul W. Kalish and Jonathan J. Madara are members of the IP Litigation team in Fox Rothschild’s Princeton, NJ office and write about patent litigation decisions in the District of New Jersey. Contact Paul at pkalish@foxrothschild.com or 609.895.6751 and Jonathan at jmadara@foxrothschild.com or 609.844.7428.

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